The Modernization of Cosmetic Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022 and is the most significant expansion of FDA’s authority to regulate cosmetics since the enactment of the Federal Food, Drug, and Cosmetic Act in 1938. On the one-year anniversary of the enactment of MoCRA, the Government Accounting Office (GAO) issued a report that included an assessment of FDA’s implementation efforts to this point and offered recommendations for facilitating the full implementation of MoCRA.
GAO Assessment of FDA’s Progress Implementing MoCRA
Although FDA has made some headway relating to the mandatory registration of cosmetic facilities, there has been very little progress made in the implementation of other provisions of MoCRA. This lack of progress is evidenced by the fact that FDA has delayed the registration and listing compliance date to July 2024 with the possibly of delaying it even further. In its report, the GAO indicated that FDA has not fully addressed the best practices and planning needs that are necessary for successful implementation of MoCRA and FDA’s execution of activities relating to the Agency’s expanded authorities under MoCRA.
Summary of GAO’s 7 Recommendations to FDA for Facilitating MoCRA Implementation
- Develop an Implementation Plan for MoCRA including a timeline, interim steps, and interim deadlines.
- Report on key milestones for all MoCRA requirements.
- Develop processes to collect needed data and evidence to measure FDA’s progress in implementing all provisions of MoCRA.
- Assess the effects of implementing all MoCRA provisions on both the current and future FDA workforce.
- Develop a multiyear Strategic Workforce Plan that identifies needed personnel and capacity, including skills and competencies to implement all MoCRA requirements.
- Develop a plan to strengthen diversity, equity, inclusion, and accessibility (DEIA) when recruiting and hiring additional staff to implement MoCRA.
- Develop a multiyear Strategic Workforce Plan for full MoCRA implementation.
So what can we expect to see from FDA in the near future?
It is obvious that over the past year, FDA has made very little progress in preparing to enforce MoCRA requirements. Now that the GAO has taken FDA to task on this lack of progress and has even offered up recommendations for facilitating (speeding up) full implementation of MoCRA, we can expect to see the start of progress in the near future. Put very simply, FDA must develop a MoCRA implementation plan, must add staffing, and must measure, monitor, and report on its own progress along these lines, and is now expected to begin this process rather quickly.
How Should the US Cosmetic Industry React to All of This?
MoCRA is here to stay…it’s not going anywhere. The only question that remains is ‘when’ will FDA begin to enforce the provisions of MoCRA?’ Since some of these provisions will require an extended period of time to achieve compliance, it is in the cosmetic industry’s best interest to prepare for MoCRA compliance now.
How can CPT Assist you in preparing to achieve MoCRA compliance?
CPT’s Analytical Chemistry, Microbiology, Clinical, Photobiology, and In Vitro Toxicology laboratories each play a role in assisting your cosmetic organization to comply with MoCRA requirements. This includes but is not limited to safety testing, microbiological testing, stability testing, screening for low level contaminants (“adulterants”), identification of allergens, and more. CPT is ready to provide consulting and testing services that can assist you in the creation of product safety dossiers, stability protocols, identification of allergens, and screening for harmful contaminants.